# FDA 483 - CardioFocus, Inc. - August 11, 2022

Source: https://www.keypedia.com/records/483/cardiofocus-inc/b85149ad-7a4d-49eb-8fd8-246799816cb4

> FDA 483 for CardioFocus, Inc. on August 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CardioFocus, Inc.
- Inspection Date: 2022-08-11
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: CardioFocus, Inc. in Marlborough, MA, underwent an FDA inspection from August 8-11, 2022, resulting in three observations. The inspection revealed deficiencies in complaint handling procedures, including failure to close a significant number of complaints and inadequate procedures for Accidental Radiation Occurrences. Additionally, the firm failed to perform required qualifications for manufacturing equipment used in catheter production.

## Related Officers

- [Nassim Ben Makhlouf](https://www.keypedia.com/people/nassim-ben-makhlouf/76a5b9f2-efe6-4ebd-89a6-8d02a5d35e0b)
- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/cardiofocus-inc/49750a9c-aa39-4080-bfaa-4edc4912b956

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94